Well I bought some March out-of-the-money calls last week - I figured that the potential upside if the Xcytrin results are good is considerable (I'd likely get near a 5-bagger or better on the options, and I figure the trial has a 50:50 shot).
Today's strength based on the very preliminary roto-rooter results was just plain luck - I had no idea that any announcements were coming. In retrospect, this is probably what accounted for last week's pop.
Tuesday September 4, 7:30 am Eastern Time
Press Release
SOURCE: Pharmacyclics, Inc.
Pharmacyclics Announces Interim Phase I Study Results of Antrin Photoangioplasty for Coronary Artery Disease
STOCKHOLM, Sweden, Sept. 4 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC - news) today announced preliminary results of its ongoing Phase I clinical trial of photoangioplasty with Antrin® (motexafin lutetium) Injection, indicating the treatment is feasible and well tolerated in patients with coronary artery disease (CAD; i.e., blockages of the arteries in the heart). The results were presented over the weekend at the 23rd Congress of the European Society of Cardiology.
``These results demonstrate for the first time in a relatively large number of patients that photodynamic therapy in the coronary arteries is feasible and well-tolerated,'' said Paul H. Kramer, M.D., Clinical Associate Professor of Medicine at the University of Missouri, Kansas City, School of Medicine, who presented the study. ``The data from this trial will form the foundation for more advanced clinical trials using this novel treatment approach aimed at eliminating the underlying inflammatory cellular component of atherosclerotic plaque.''
In this Phase I drug and light dose escalation study designed to evaluate the safety of this experimental therapy in treating patients with blocked coronary arteries, Antrin was administered intravenously 18 to 24 hours before patients underwent standard balloon angioplasty and stent placement. Photoangioplasty was performed on the balloon-treated vessel segment before placement of a stent, all in a single cath lab procedure.
Sixty patients received Antrin with subsequent activation of the drug by light delivered endovascularly to the site of the angioplasty using an optical fiber catheter. Fifty-eight patients had follow-up coronary angiography at six months. No major treatment-related angiographic or biochemical adverse effects or abnormalities were observed and no dose-limiting toxicities were noted. No instances of emergency coronary artery bypass, death, stroke or myocardial infarction were seen in patients who received both drug infusion and endovascular illumination and activation of drug. The most frequently reported side effects were mild, transient chest pain, rash and reversible mild tingling in the hands and feet, some of which lasted days to weeks, but did not require clinical intervention.
The Phase I study, which is being conducted at seven leading medical centers in the United States, will enroll a total of about 75 patients. The longer-term goal of the CAD clinical program is to establish the safety and effectiveness of Antrin photoangioplasty in the potential treatment of atherosclerosis by eliminating the inflammatory component of the disease.
``We are excited about these results because they indicate that the drug and light doses we tested can be used in a Phase II efficacy trial, which we are designing now,'' said Daniel C. Adelman, M.D., senior director of clinical development at Pharmacyclics. ``We also observed that Antrin photoangioplasty is relatively easy to perform and does not require much of a learning curve for cath lab personnel.''
Principal investigator Dean J. Kereiakes, M.D., Medical Director of the Carl and Edyth Lindner Center, Director of Research at the Ohio Heart Health Center and Professor of Clinical Medicine at the University of Cincinnati College of Medicine, will present additional Phase I trial data and may perform a live case demonstration of this procedure later this month at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, D.C. Daniel I. Simon, M.D., Associate Director of Interventional Cardiology at Brigham & Women's Hospital and Associate Professor of Medicine at Harvard Medical School in Boston, will be presenting other work at TCT discussing Antrin's proposed mechanism of action.
``Antrin photoangioplasty appears to promote a redox-sensitive apoptotic cell-death pathway in vascular cells,'' said Dr. Adelman. ``This novel, potentially non-traumatic approach appears to target the inflammatory and smooth muscle cells that drive the disease process and may reduce plaque cellularity by the induction of apoptosis.'' |
